ArticleJournal of clinical pharmacy and therapeutics2020
Assessment of factors associated with completeness of spontaneous adverse event reporting in the United States: A comparison between consumer reports and healthcare professional reports.
Article in Journal of clinical pharmacy and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.
- Empowering citizens to spontaneously report suspected adverse drug reaction: Systematic literature review of interventions and their impact.British journal of clinical pharmacology · 2026Pooled it
- Development and application of the vaccine reporting quality score to evaluate the vaccine adverse event reporting system.Frontiers in immunology · 2026Article
- Real-world pharmacovigilance assessment of meropenem-associated adverse events: age stratification and time-to-onset analysis using FAERS.Frontiers in medicine · 2026Article
- Factors associated with the completeness of information provided in adverse drug reaction reports of physicians, pharmacists and consumers from Germany.Scientific reports · 2025Article
- Article
- Trends in Adverse Event Reporting Before and After the Introduction of the Med Safety App in Nigeria.Pharmaceutical medicine · 2024Observational
- Data-Driven Identification of Factors That Influence the Quality of Adverse Event Reports: 15-Year Interpretable Machine Learning and Time-Series Analyses of VigiBase and QUEST.JMIR medical informatics · 2024Article
- Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers.Drug safety · 2023Article
- Characteristics and completeness of spontaneous reports by reporter's role in Germany: An analysis of the EudraVigilance database using the example of opioid-associated abuse, dependence, or withdrawal.Pharmacology research & perspectives · 2023Article
- Variation in adverse drug events of opioids in the United States.Frontiers in pharmacology · 2023Article
- Author's Reply to Joerg Putzke et al. Comment on: "Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database".BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Article
- Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Article
- Assessment of factors associated with completeness of spontaneous adverse event reporting in the United States: A comparison between consumer reports and healthcare professional reports.Journal of clinical pharmacy and therapeutics · 2020Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
Abstract
WHAT IS KNOWN AND
objectiveThe objectives of this study were to explore completeness of direct adverse event (AE) reports from consumers and healthcare professionals (HCPs), and to discuss the reasons completeness varied among reporters with different occupations.
methodsWe used a total of 5475 direct AE reports to the United States (US) Food and Drug Administration (FDA) from the first and second quarters of 2016 and assessed completeness of basic information (eg, patient sex, age, weight) and information relevant to AEs (eg, suspect and concomitant drugs). Logistic regression analysis was conducted to evaluate the associations between report completeness and reporting backgrounds. RESULTS AND DISCUSSION: The completeness of AE reports from consumers was generally greater than that of reports from HCPs. Completeness of specific items varied among different occupations, which may reflect accessibility to, and/or availability of, relevant information for each type of reporter. There was a clear association between the proportion of 'known' ADRs in a report and completeness, suggesting that consumers and HCPs are likely to consult labelling information when reporting AEs. WHAT IS NEW AND
conclusionThe quality of AE reports seemed to depend on information costs accrued to potential reporters. Researchers should consider the impact of database heterogeneity and possible sample selection bias when using spontaneous AE reports as a sample of events in the United States.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.